Investor Presentaiton

17 Accelerated Approval Trial Design in First-Line HLA-A2 Negative MUM FDA Guided Design: Open Label Ph2/3 Evaluation of Daro + Crizo vs. Investigator's Choice FDA Project Front Runner: Target First-Line approval strategy to enhance patient benefit in MUM FDA Accelerated Approval: Address unmet need in MUM, which has limited effective treatment options Integrated Phase 2/3 Study within Study Enables Potential Accelerated Approval & Full Approval Targeting FPI Q3 2023 Median PFS Median OS Phase 2 A Daro + Crizo Investigator's Choice Phase 3 2:1 Randomization ~230 Ph 2/3 Patients + 2:1 Randomization +~120 Ph 3 Patients Accelerated Approval Full Approval FDA Fast Track Designation for Daro + Crizo in MUM A Nested study to confirm move forward dose: (i) Daro 300 mg BID + Crizo 200 mg BID or (ii) Daro 200 mg BID + Crizo 200 mg BID Phase 2 study contemplates data set of n=200 patients randomized 2:1 with treatment arm at move forward dose in support of potential accelerated approval based on mPFS Daro Darovasertib, Crizo = Crizotinib, MUM-Metastatic Uveal Melanoma, HLA-A2 = HLA-A2*02:01 Serotype, IC = Investigator's Choice, Ipi = ipilimumab, nivo = nivolumab; DTIC = dacarbazine 2:1 Randomization Daro + Crizo vs Investigator's Choice (IC = Ipi + Nivo, PD1, or DTIC) Primary Endpoints (BICR) Accelerated Approval: mPFS Full Approval: mOS IDEAVA BIOSCIENCES

View entire presentation